GSPR Checklist Template - IVDR 2017/746

ISO 13485 - QMS.4.2.3.1.4 - GSPR Checklist Template IVDR 2017/746

The General Safety and Performance Requirements (GSPR) checklist is a checklist against annex I of the In Vitro Diagnostic Device Regulations (IVDR) EU 2017/746. The device needs to be assessed against each clause of annex I, and evidence presented on how the requirements has been met and where the evidence is located, or a justification as to why the requirement is not applicable, just writing not applicable is not sufficient. This template provides a full list of annex I clauses and formatted to easily present the data required to demonstrator conformity to the IVDR.

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